Chronic Lyme disease: A dubious diagnosis

With a lime-green Lyme disease advocacy ribbon pinned to his dapper black suit, Raxlen joined partygoers sipping martinis below a stained-glass skylight bigger than most New York City apartments.Money was in the air. The "Unmask A Cure" gala invitation listed Goldman Sachs, New York Private Bank & Trust and Marquis Jet as sponsors. The event raised money for the Turn the Corner Foundation, a Lyme nonprofit on whose medical advisory board Raxlen sat.

The scene was light-years from the institutional brick building where the Connecticut Medical Examining Board was considering disciplinary action against Raxlen for the fourth time in 10 years. Raxlen had been accused of telling a woman dying of Lou Gehrig's disease that she had chronic Lyme disease, an illness that might not even exist.

Lyme disease is real. The bacterial infection, chiefly transmitted by deer ticks, can cause rashes, swollen joints and inflamed nerves, and usually is curable with a round of antibiotics.

But doctors around the country are telling patients with common medical problems such as back pain, poor concentration and fatigue that their ailments stem from a chronic form of Lyme disease that can evade standard treatment and wreak havoc for years. To fight what they believe is a persistent infection, the doctors often order months or years of intravenous antibiotics, which can cost tens of thousands of dollars.

Strong evidence isn't on their side. But in a golden age of dubious medicine, that doesn't matter.

These days, advocates can raise big money to "Unmask A Cure" for a disease that already has a cure, and doctors disciplined by medical boards are held up as heroes. Legislatures around the country are passing laws to prevent medical boards from disciplining doctors who treat what they consider chronic Lyme with therapies that clinical trials have shown are dangerous and don't work.

In October, a New Jersey congressman entered into the Congressional Record a statement from three nonprofit Lyme groups chastising the federal Institutes of Medicine for a "pervasive lack of objectivity" when it comes to chronic Lyme.

Fueled by suspicion of doctors and drug companies, Americans are flocking to alternative healers promoting risky treatments and unproven cures. The Internet connects pseudoscientists with the desperately ill, trumpets I've-been-cured testimonials and often dismisses the results of clinical trials as the work of unsympathetic doctors corrupted by Big Pharma money.

Google "ALS" and "treatment" and results include a site touting deer antler therapy for amyotrophic lateral sclerosis, also known as Lou Gehrig's disease. Google "cancer" and "alternative treatments" and you'll find a "grape cure," among others. Message boards are packed with patients trading treatments, often including detailed prescription information.

In this world, skeptics are vilified as part of a vast conspiracy involving tainted government agencies, drug companies, the media and conventional physicians. Scientific studies are cited but are invariably of poor quality or misinterpreted. Patients are directed to small specialty labs offering tests that can be misleading.

And advocacy groups are aggressive and sophisticated about spreading their messages, raising money and influencing state and federal lawmakers.

There is no better example than the world of chronic Lyme, a disease that might not exist and one for which the most common treatment, months or years of antibiotic use, poses a threat to us all by sapping the power of those drugs to fight disease.

'It is all Lyme'

Kimberly Frank describes herself as always "going, going, going" before she got sick about 10 years ago. At the time, she was running two bridal shops, raising her four children and caring for two foster children.

Then the Ingleside mother developed crippling fatigue and an array of symptoms that baffled doctor after doctor. She says a physician diagnosed her with multiple sclerosis. Later, a different one told her she had Lyme disease.

To feel better, Frank says, she has taken up to 76 pills a day. She says she has been on oral or IV antibiotics for three years. Two of her children also have Lyme, she says, and have been on antibiotics.

Frank, who runs a northwest suburban Lyme support group, told the Tribune in an interview that she suspects Lyme is "man-made" and was developed at the federal Plum Island Animal Disease Center in New York.

Frank says Lyme is tragically underdiagnosed, that tests endorsed by the Centers for Disease Control and Prevention are unreliable, and that research into the disease will unlock many mysterious and devastating illnesses.

"They are finding that people who are diagnosed with ALS, Parkinson's, fibromyalgia -- it is all Lyme disease," she said. "It is faster-growing than AIDS or cancer."

Many of these ideas are central to the chronic Lyme movement, which has gained such momentum that support groups have popped up in just about every state, even though infected ticks live mostly in Minnesota, Wisconsin and the Northeast.

In Illinois, Lyme cases that meet the CDC surveillance definition and are reported to the government are rare, yet enough patients think they have chronic Lyme that multiple support groups exist around the state.

Robert Bradford, founder of the Robert Bradford Research Institute in California, has called Lyme the "potential plague of the 21st century," likening it to the Black Death, estimated to have killed one-third of the population of medieval Europe. Bradford said Lyme disease might be a contributing factor in as many as half of all cases of chronic illness.

Yet the nation's largest professional organization for specialists in infectious disease scrutinized the evidence and concluded that there is "no convincing biologic evidence" for a Lyme infection that persists and continues to sicken despite the recommended treatment, usually a few weeks of antibiotics.

Three panels of experts from that organization, the Infectious Diseases Society of America, and one panel from the American Academy of Neurology came to the same conclusion: The diagnosis is suspect, and treatment with antibiotics long-term is unsupported and risky.

"I don't think of it as a mysterious disease that causes a lot of vague symptoms," said Steere, a professor at Harvard Medical School who has spent decades studying Lyme disease and sat on two of the expert panels. "It doesn't."

The evidence against the effectiveness of long-term antibiotic therapy is especially strong -- supported by four randomized, double-blind, placebo-controlled clinical trials.

Patients in three trials receiving long-term antibiotic therapy did not do significantly better than those receiving placebos. In one other trial, patients receiving antibiotics felt significantly less fatigued than those receiving the sham treatment, though many of the antibiotic patients figured out they were receiving medicine, a grave flaw in the study.

Dr. Robert Bransfield, a psychiatrist and president of the nonprofit International Lyme and Associated Diseases Society, said that the trials had too narrow a definition of Lyme, weren't representative of the typical patient and didn't treat the subjects with the proper antibiotics for enough time.

Lyme bacteria "do not dance to the three- to six-week rumba" of antibiotic treatment, said Raxlen, the Lyme doctor honored by the Turn the Corner Foundation, adding that scientists who say chronic Lyme doesn't exist are part of "the flat Earth society."

"I see a persistent population of very ill people that respond to aggressive long-term antibiotic therapy," Raxlen said. "It literally turns their lives around."

However, the clinical trials on long-term antibiotic therapy found it can cause serious, even life-threatening problems. In one study, one-fourth of the patients suffered severe problems linked to the treatment, including blood clots, infection and the loss of a gallbladder.

Given the lack of benefits, "why take needless risks with people's lives?" said Dr. Paul Lantos, a pediatric infectious disease physician with Duke University Medical Center who served on the latest Lyme disease review panel.

Last year, a 52-year-old chronic Lyme patient in Minnesota died after 10 weeks of antibiotic use allowed a drug-resistant strain of bacteria to develop. Two of her doctors found no objective evidence to support a Lyme diagnosis before a third prescribed antibiotics long term, according to a letter in the journal Clinical Infectious Diseases.

Such use of antibiotics poses a potential danger to the public, as some of the drugs prescribed to chronic Lyme patients are society's last-resort weapons against deadly bacteria. The more we use antibiotics, the faster bacteria become resistant, making these lifesaving medicines obsolete. Already, drug-resistant bacteria kill thousands of people every year in the United States.

That risk is worth taking when the antibiotics are used to cure an infection. But the unnecessary use of antibiotics poses a risk to everybody, said Dr. Louis Rice, an expert on drug resistance who is chair of medicine at Brown University's medical school.

There is no powerful lobbying group for patients suffering from drug-resistant infections, Rice said. "They can't scream outside the White House."

Tell people often enough that their pain is in their head, that their debilitating symptoms are medically unexplainable, and they will endure just about anything for a solid diagnosis and a possible cure.

In addition to being given antibiotics for months, people in search of answers and hope have allowed doctors to infect them with malaria, to treat them with weedkillers, to inject them with a heavy metal -- all for the promise of killing elusive Lyme bacteria.

Around the country, chronic Lyme patients say they've spent tens of thousands of dollars each on therapies that made them sick for an illness they never had.

Dr. Carol Ann Ryser, a Kansas City, Mo., doctor, has faced malpractice lawsuits from 11 former patients who say she misdiagnosed them with Lyme disease and harmed them with antibiotics and other medicines. Ryser's malpractice insurers have paid more than $2 million in settlements to former Lyme patients, court records show.

Crystal Hotchkiss, a 21-year-old Kansas woman who sought treatment for pain, said Ryser misdiagnosed her with Lyme. Hotchkiss said she suffered a heart attack, vomited blood and spent three weeks in critical care in 2008 at a Kansas hospital after undergoing months of infusions of antibiotics and other treatments Ryser ordered, according to court records.

FBI agents raided Ryser's office, home and car in September 2009, carting away 211 patients' charts, computer hard drives and other files, Ryser said in a deposition in one of the malpractice cases. She has not been charged with a crime.

The Missouri medical board is seeking to discipline Ryser, alleging that she misdiagnosed patients with Lyme disease and overcharged them for unnecessary treatments that "might have been harmful or dangerous." One patient cashed in her 401(k) account to pay the $15,000 monthly fees for treatment, the board said.

Ryser denied the allegations in the malpractice cases and the medical board complaint. Her civil settlements included no admission of liability, said her attorney, Jacques Simon. "She treated them properly and the patients were getting better," he said.

A handful of the promoters of chronic Lyme disease have criminal records. Bradford, who sounded the alarm about the Lyme "plague," pleaded guilty in September to a federal felony conspiracy charge. He admitted that he inflated fears about Lyme so he could sell drugs to treat it, even though they were never approved by the Food and Drug Administration, according to his plea agreement.

Bradford, who is not a medical doctor, and his co-conspirators earned more than $400,000 from sales of the drugs, which were made with chemicals never intended for use in drugs for humans or animals, according to the plea agreement. One of the Lyme drugs, which Bradford called bismacine, contained the heavy metal bismuth, high levels of which can cause kidney failure.

Bradford was no stranger to questionable medicine: He has a 1977 federal conviction for conspiracy to smuggle a banned cancer treatment.

Michael Harris, Bradford's attorney in the current Lyme case, said his client has a narrower view of the conspiracy detailed in his plea agreement. Harris said Bradford admits it was a crime that his family's company was not registered with the FDA to manufacture drug components, adding that the company earned less than $5,000 from the sale of bismacine.

Treatment with bismacine has had deadly consequences, according to the plea agreement. Beverly Wunder, a Kansas Lyme patient, lapsed into a coma after she was infused with bismacine in 2005. She died a year later at age 47.

Dr. John Toth, Wunder's physician, was indicted along with Bradford and pleaded guilty to a felony conspiracy charge in October. Toth also pleaded guilty to a state charge of reckless involuntary manslaughter in Wunder's death and served time in a Kansas prison.

In the state case, Wunder's daughter, Melanie Bezner, said in a courtroom packed with Toth's supporters that her mother never had Lyme disease.

"But a doctor's greed and disregard for medical regulations and the value of human life cost my mother hers and has forever altered mine," Bezner said.

Political victories

Rather than be alarmed by doctors who have drawn scrutiny, chronic Lyme advocates have feted many of them, packed medical board hearings in support and appointed them to their boards.

Five of the 20 members of the medical advisory board of the Turn the Corner Foundation -- the Lyme group that says it has raised more than $4 million -- were disciplined by state medical boards or agreed to stricter oversight by state medical authorities in order to avoid misconduct charges.

Bernard Raxlen, the doctor who received an award at the 2008 Turn the Corner Foundation gala, has faced four disciplinary cases before the Connecticut medical board in the past decade.

The current case initially involved charges that Raxlen told a Massachusetts woman with fatal Lou Gehrig's disease that she had a Lyme infection and treated her with an illegal drug from Germany. After years of legal wrangling, what remains are charges that Raxlen, as a psychiatrist, failed to diagnose and treat the patient for severe depression or refer her for such an exam and failed to consider any diagnoses other than Lyme.

In an interview, Raxlen said the patient did have Lyme disease. He said the relationship between Lyme and Lou Gehrig's disease "is unclear." (Last year, experts on ALS wrote in a journal devoted to the disease: "There is no convincing evidence that ALS can be caused by Lyme disease.")

Raxlen said he is proud of his medical record. Charges of patient harm have been repeatedly dismissed. He has been sanctioned twice for lesser charges related to his failure to turn over patient records to the medical board or insurers. Charges in 2003 related to a Lyme patient's suicide were dropped entirely.

"I've never been reprimanded for my clinical judgment," Raxlen said.

Stacey Sobel, executive director of the Turn the Corner Foundation, says it's a shame Raxlen and other doctors in the movement have been disciplined. "We look at them as doctors who are trying to help Lyme patients," she said.

While they have lost the scientific battle so far, chronic Lyme activists are winning politically. In recent years, they have persuaded politicians in 13 states to introduce Lyme-friendly bills, many of which prevent medical boards from disciplining doctors for treating Lyme with antibiotics long-term.

Lyme-friendly laws have passed in Connecticut, Rhode Island, California and Massachusetts. Legislators in Minnesota dropped their Lyme doctor-protection bill only after the state medical board in March agreed to a five-year ban on investigating and disciplining physicians for treating chronic Lyme disease with long-term antibiotic therapy unless a patient or his parent or guardian lodges a complaint.

In Connecticut, Rep. Kim Fawcett last year won unanimous approval for her bill forbidding the medical board from disciplining doctors for diagnosing and treating chronic Lyme with long-term antibiotic therapy. Fawcett, whose husband was diagnosed with Lyme, said she overcame opposition to the bill from Yale University doctors because of the powerful stories of constituents who said they were suffering with the disease.

It can be an uphill battle getting politicians to side with science when sick patients testify that long-term antibiotic treatment helped them, said infectious disease physician Dr. Jeffrey Parsonnet, who testified against a New Hampshire doctor-protection bill.

"It is all focused on either siding with the big, rich doctors with their BMWs or this poor person who is suffering and misdiagnosed," said Parsonnet, a professor of medicine at Dartmouth Medical School.

The biggest boon to the chronic Lyme movement came when Connecticut Attorney General Richard Blumenthal launched an antitrust investigation of the Infectious Diseases Society of America panel that set Lyme treatment guidelines in 2006. The panel was made up of some of the world's top experts in Lyme disease.

But Blumenthal, soon to be a U.S. senator, said the society undercut its credibility by empaneling doctors who consulted for insurers and had financial interests in drug companies and Lyme disease diagnostic tests. A spokeswoman for the Infectious Diseases Society of America (IDSA) said the panelists did not benefit financially from the guidelines, which recommend generic drugs and lab tests.

Because of a 2008 agreement between Blumenthal and the IDSA, a new panel considered evidence submitted by all sides. Panelists were screened by an independent ombudsman to ensure they had no significant financial ties to Lyme disease.

In April, the panel released its report. It agreed with the 2006 panel: The evidence for chronic Lyme disease was weak, and long-term antibiotic treatment was dangerous and ineffective.

As is often the case in this era of dubious medicine, the scientific review did not put the issue to rest. Instead, the panel's decision was a call to arms for chronic Lyme advocates.

On a popular blog for Lyme sufferers, Ashley van Tol wrote that "infecting the committee members with Lyme sounds great because we are pissed off."

After acknowledging that would not be "realistic or appropriate," van Tol went on to urge readers to make their voices heard, because personal stories are more powerful than scientific guidelines.

"In a competition between posting the IDSA guidelines or your Lyme story," she wrote, "it is going to be you that they choose to read about."